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Steroids for Early Treatment of Radiation Retinopathy

Primary Purpose

Radiation Retinopathy

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluocinolone Acetonide (FA) implant
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation Retinopathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary uveal melanoma
  • Primary treatment with plaque brachytherapy
  • Baseline visual acuity 20/200 or better
  • Posterior tumor margin >1.50 mm from the center of the macula
  • Posterior tumor margin > 1.50 mm from the closest disc margin
  • Calculated total dose to center of the macula >40 Gy

Exclusion Criteria:

  • Iris melanoma
  • Opaque media
  • less than 21 years of age
  • Inability to give consent
  • Positive pregnancy test

Sites / Locations

  • Cole Eye Instiute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Observation

Intervention

Arm Description

The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula. These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to either observation (2:1) (standard of care).

The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula.1 These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to intravitreal Fluocinolone Acetonide (FA) implant.

Outcomes

Primary Outcome Measures

Central subfield retinal thickness by OCT scan
Anatomic outcome

Secondary Outcome Measures

Best corrected visual acuity
Functional outcome Best corrected Visual acuity and Visual field defect

Full Information

First Posted
July 31, 2017
Last Updated
August 2, 2021
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03238157
Brief Title
Steroids for Early Treatment of Radiation Retinopathy
Official Title
Steroids for Early Treatment of Radiation Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and acute inflammatory effects of radiation in various tissues.
Detailed Description
The purpose of the project is threefold: To study the natural history of radiation retinopathy using advanced imaging techniques. A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia and leakage. Potential role of OCT angiography in radiation retinopathy will be evaluated by comparison to other eye (control) and FA. Currently there is no consensus on effective management strategy for radiation retinopathy. Patients in the interventional will be prospectively followed to study efficacy of steroids for early treatment of radiation retinopathy while comparing the multimodal therapeutic approach in a randomized trial. Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation
Arm Type
No Intervention
Arm Description
The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula. These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to either observation (2:1) (standard of care).
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula.1 These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to intravitreal Fluocinolone Acetonide (FA) implant.
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide (FA) implant
Other Intervention Name(s)
Steroid
Intervention Description
Fluocinolone Acetonide (FA) implant is designed to release FA at an initial rate of approximately 0.6 g/d, decreasing over the first month to a steady rate of 0.3 to 0.4 g/d with a duration of approximately 30 months.
Primary Outcome Measure Information:
Title
Central subfield retinal thickness by OCT scan
Description
Anatomic outcome
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Functional outcome Best corrected Visual acuity and Visual field defect
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Need for standard of care intervention
Description
standard of care intervention with laser photocoagulation and/ or anti VEGF agents
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary uveal melanoma Primary treatment with plaque brachytherapy Baseline visual acuity 20/200 or better Posterior tumor margin >1.50 mm from the center of the macula Posterior tumor margin > 1.50 mm from the closest disc margin Calculated total dose to center of the macula >40 Gy Exclusion Criteria: Iris melanoma Opaque media less than 21 years of age Inability to give consent Positive pregnancy test
Facility Information:
Facility Name
Cole Eye Instiute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Steroids for Early Treatment of Radiation Retinopathy

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